To try a known antiretroviral combination in HIV infected children with only one pill taken a day, in order to simplify the prescription and improve adherence to treatment. This is what is called a clinical trial phase II, only recruiting and following during one year a small number of children (50) to evaluate the quantity of drug in blood just before the taken and one to three hours after the taken. The other important objective is to study the tolerance of drugs in that mode of prescription of the triple combination.

Condition	Intervention	Phase
HIV Infection AIDS	Drug: Efavirenz  Drug: Lamivudine  Drug: Didanosine	Phase II

Further Study Details: 

Primary Outcomes: Percentage of patients with HIV RNA less than 400 copies per ml and less than 50 copies per ml at M12; Cmin and Cmax for the three drugs; Grade 3 or 4 undesirable effects frequency
Secondary Outcomes: Percentage of patient with CD4 over 25 percent at M12; Amplitude of Viral load reduction; Slope of CD4 compared with the initial values; Percentage of patients lost of follow up; Percentage of deaths and of B or C classing events; Percentage of treatment interruption; Percentage and type of resistances mutations; Percentage of patients forgetting more than one pill within the last three days
Expected Total Enrollment:  50

The data relating to pharmacology tolerance and efficacy of the once-daily combination of 3TC + ddI + EFV have never been studied. This regimen may lead to a better treatment of the HIV-1 infected children in developing countries, as well as in Europe. Because of its simplicity it would facilitate observance that is one of the essential parameters of efficacy of treatments.

The main objectives are those of a phase II clinical trial : - Assess the virological and immunological efficacy of a once daily HAART regimen comprising Lamivudine-3TC + Didanosine-ddI + efavirenz–EFV (pediatric reference) - Analyse the pharmacological characteristics of this combination in children - Assess the tolerance - Study the appearance of resistances - Evaluate the observance to treatment

50 HIV-1 infected children aged 30 months to 15 years whose clinical and immunological state (stage B or C) requires antiretroviral treatment, will be included in the study. They should be naive of any ARV treatment (except the treatment received in the framework of PMTCT(Prevention of Mother to Child Transmission)).

Data collection and development of the study : Monthly clinical examination, RNA HIV-1 and CD4 counts, Pharmacological dosages, Haematology and biochemistry surveillance, Genotypic resistance at inclusion and in case of unsuccess or failure, Assessment of observance according to alternate methods.

Laboratory examinations will be carried out at Centre Muraz except for genotyping and for pharmacological test sent to Montpellier Teaching Hospital (France).

Ages Eligible for Study:  30 Months   -   15 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• HIV-1 infected children
• weight over 12 kgs
• age over 30 months
• clinical stage requiring HAART
• naive to antiretroviral treatment (except PMTCT prophylaxis)
• mothers'''' or tutor’s informed consent signed

Exclusion Criteria:

• HIV-2 or dual HIV infection
• Previous antiretroviral therapy
• Children unable to swallow pills
• Known resistance to NNRTI

Please refer to this study by ClinicalTrials.gov identifier  NCT00122538

Philippe Msellati, MD      00 226 76 52 07 99    philippe.msellati@ird.bf

Burkina Faso
      Service de pediatrie, CHU Sanou Souro, Bobo-Dioulasso,  01 BP 676,  Burkina Faso

Study chairs or principal investigators

Philippe Msellati, MD,  Study Chair,  Institut de Recherche et de Développement (IRD UMR 145)   
Aboubacar Nacro, MD,  Principal Investigator,  CHU Sanou Souro, Bobo-Dioulasso   

Study ID Numbers:  ANRS 12103
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122538
Health Authority: Burkina Faso: Ministry of Health
ClinicalTrials.gov processed this record on 2005-07-26